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Geron Ends 327-Patient Myelofibrosis Trial After Monitors Say It Is Unlikely To Show Survival Benefit

An independent committee advised Geron that its imetelstat study would likely miss its survival goal, and Nasdaq halted the stock Wednesday.

Matteo Parrino Jonathan Ponciano

Matteo Parrino, Jonathan Ponciano

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Geron Ends 327-Patient Myelofibrosis Trial After Monitors Say It Is Unlikely To Show Survival Benefit

Geron, a commercial-stage hematology drugmaker, said Wednesday it is discontinuing its Phase 3 IMpactMF trial of imetelstat in myelofibrosis after an independent Data Monitoring Committee advised that the study was unlikely to meet its main goal, overall survival. Nasdaq had halted GERN trading at 7:55 a.m. ET under code T1, news pending.

A late-stage trial stopped early

The trial enrolled 327 patients with intermediate-2 or high-risk myelofibrosis, a bone marrow cancer, whose disease had relapsed or stopped responding to a JAK inhibitor. Patients were randomized 2:1 in an open-label study, meaning everyone knew which treatment they received, to imetelstat or best available therapy.

Those in the imetelstat arm received 9.4 mg/kg intravenously every three weeks. The study was designed to test whether the drug improved survival compared with best available therapy.

The company said no new safety signals emerged that change imetelstat's known safety profile or call for added monitoring. A detailed data analysis will follow, and Geron said it will share findings with the scientific community at a future date.

What Geron says comes next

Geron sells Rytelo, the brand name for imetelstat, which is approved in the United States and European Union for certain patients with lower-risk myelodysplastic syndromes, or LR-MDS. The myelofibrosis trial was a separate effort to extend the drug into another blood cancer.

Chief Executive Harout Semerjian said that as the company analyzes the trial data, it remains committed to "growing RYTELO demand in the U.S. and broadening access to eligible LR-MDS patients outside the U.S."

Joseph E. Eid, Geron's executive vice president of research and development and chief medical officer, said that given the committee's recommendation, ending the trial "at this time is the right course of action."

Halt and the stock

Nasdaq stopped trading in the shares before the announcement, at 7:55 a.m. ET on Wednesday, with no resumption time posted. GERN last traded at $0.97 in Wednesday's market data.

Geron's next step is the detailed IMpactMF analysis, which it plans to present to the scientific community at a future date.

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